The US Food and Drug Administration (FDA) has approved the use of a drug remedicator to treat the new novel coronavirus disease Code 19.
It is the first drug to be approved for the treatment of patients with code-19 in which the disease is more severe.
The FDA announced on Friday that although information on the drug’s safety or efficacy is limited, a clinical trial this week found that its use could improve the health of some patients. The process speeds up.
Remedicator is an experimental antiviral drug developed by the American company Gilad Sciences for Ebola patients but is now being used for Covarna virus patients.
The drug is used by medical experts in patients with low blood oxygen levels and in need of oxygen therapy or ventilator.
The U.S. National Institute of Allergy and Infectious Diseases reported Wednesday, citing a U.S. clinical trial, that the drug was clearly better suited to treat code 19 and helped patients recover faster.
Dr Anthony Fauchi, the institute’s director, said preliminary results were important evidence that the drug could block the virus.
One thousand patients were included in the trial in which the recovery rate was 31% faster and the death rate was slightly lower.
As noted above, the drug was developed for Ebola but failed in trials of its patients. However, a 2017 study found that it is effective against human corona viruses.
Gilad Signs says the US federal government will decide who needs the drug the most because its supply is currently limited.
“We are working with the US government to distribute the drug,” the company said.
“We will work with our international partners to increase the supply of the drug and further the ongoing clinical trials on the efficacy of the drug,” the company’s CEO Daniel Oday said in an emailed statement. ۔
There have been numerous trials of Code 19 patients around the world on remediators and it is being given more importance than other drugs.
Interestingly, a study in China on remedicator did not find its effects to be more beneficial than other drugs.
Research in China was halted at an early stage due to a shortage of patients, and other medical experts called the results incomplete.
Effective treatment against code 19 will be an important milestone as patients with code 19 are currently being tested for drugs that have not been approved.
The remediator is given by injection and has so far been tested on patients undergoing treatment in the hospital and has not been tested for preventive treatment or to help patients with mild symptoms.
The trial results for the drug were released at a Chicago hospital in mid-April.
At the University of Chicago Medicine, 125 patients with code 19 were included in the third phase of the pharmaceutical company’s clinical trials.
The severity of the disease was higher in 113 out of 125 patients and for the treatment of all these patients, remedial fluid was injected daily into the body.
“The good news is that most of our patients are now discharged, with only two patients left,” said Dr. Kathleen Mullen, an epidemiologist at the University of Chicago who oversees the research on this experimental drug.
The results showed that with the use of this drug, the patients’ fever and respiratory symptoms disappeared very quickly and in less than a week, all the patients were declared healthy and discharged from the hospital.
“It’s very difficult, because the study did not compare other drug users, but when we started using the drug, we saw,” said Dr. Kathleen, who declined to give a clear result. As the severity of the fever began to decrease, we saw that when the patient came with a high fever, the medicine would immediately reduce it. We saw people coming out of the ventilators only one day after the treatment, so overall. This medicine worked very well on our patients.
“Most of our patients had very severe illnesses and most of them were discharged in 6 days, so we can say that the duration of treatment was not 10 days, very few patients, maybe 3 people were like that,” he said. Who were discharged in 10 days.
Gilead’s serious cases have involved 2,400 patients in 152 different clinical trials around the world, while separate trials are being conducted on 1,600 moderate patients in 169 different centers.
In these trials, research is being done on 5- and 10-day treatment courses with medicine and the main objective is to see which of the two courses is more effective for patients.
Earlier, a study published in the New England Journal of Medicine on April 10 found that the drug was used in a small group of patients and that the condition of the majority of them had improved significantly.
The study included 53 patients from the United States, Europe and the United Kingdom, 50% of whom were placed on a ventilator when their condition worsened, while 4 were connected to a heart-link bypass machine. ۔